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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-502881-25-00 | Other Identifier | EU CT Number |
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Study terminated due to business and strategic decision
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| Name | Class |
|---|---|
| Centessa Pharmaceuticals plc | INDUSTRY |
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The purpose of the study is to evaluate the efficacy, safety, tolerability and pharmacokinetic (PK) profile of prophylactic SerpinPC in participants with Hemophilia B with inhibitors, as part of the SerpinPC registrational program.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SerpinPC | Experimental | Participants will receive SerpinPC 1.2 milligrams/kilogram (mg/kg) subcutaneous (SC) injection every 2 weeks (Q2W) for 48 weeks after a prospective observation of 12 weeks for all participants, either in a prior non-interventional study (AP-0105[NCT05605678]) or as part of the ongoing study observational period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SerpinPC | Drug | Administered as SC injection. |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Annualized Bleeding Rate (ABR) for Treated Bleeds up to Week 24 | Up to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Annualized Bleeding Rate (ABR) for Treated Bleeds Up to Week 48 | Up to Week 48 | |
| Annualized Bleeding Rate (ABR) for Treated Spontaneous Bleeds | Up to Week 48 | |
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Inclusion Criteria:
Effective contraceptive measure include condom with or without spermicide, a combination of male condom with either cap, diaphragm, or sponge with spermicide (double barrier methods), vasectomy, partner using stable contraceptive measures (combined [ estrogen and progestogen-containing] hormonal contraception or progestogen-only hormonal contraception initiated 2 or more menstrual cycles prior to screening, intrauterine device [IUD]. Intrauterine hormone-releasing system [IUS], bilateral tubal ligation), and/or sexual abstinence.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado School of Medicine | Aurora | Colorado | 80045-7202 | United States | ||
| University of South Florida |
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| Annualized Bleeding Rate (ABR) for Treated Spontaneous Joint Bleeds |
| Up to Week 48 |
| Total Coagulation Factor and/or Bypass Product Consumption During SerpinPC Treatment | Up to Week 48 |
| Pharmacokinetic Concentrations of SerpinPC | From Day 1(Pre-dose) up to Week 48(Post-dose) |
| Haemophilia Quality-of-Life Questionnaire for Adults (Haem-A-QoL) Physical Health Scale | The Haem-A-QoL instrument contains 44 items across 10 domains relevant to HRQoL in adults (physical health, feelings, view of participant's self, sports and leisure, work and school, dealing with hemophilia, treatment, future, family planning, partnership, and sexuality). Each item is rated on a 5-point scale (1=never, 2=rarely, 3=sometimes, 4=often, 5=all the time). Higher scores are indicative of greater impairment in HRQoL. | From Baseline up to Week 48 |
| Number of participants with Adverse events (AEs) | From Baseline up to Week 52 |
| Number of Participants with Persistent High-titer Antidrug Antibodies (ADAs) | From Baseline up to Week 48 |
| Number of Participants with Severity of Injection-site Reactions | Baseline up to Week 44 |
| Tampa |
| Florida |
| 33612 |
| United States |
| East Carolina University | Greenville | North Carolina | 27834 | United States |
| Centre of Haematology named after prof. R. O. Yeolian/ Hemophilia center | Yerevan | 0014 | Armenia |
| Royal Prince Alfred Hospital | Camperdown | New South Wales | 2050 | Australia |
| The Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
| Hopital Bicetre | Le Kremlin-Bicêtre | 94270 | France |
| CHRU de Lille Centre de biologie et pathologie | Lille | 59000 | France |
| Hospices Civils de Lyon (HCL) - Hopital Femme-Mere-Enfant (HFME) | Lyon | 69500 | France |
| Hopital Necker - Enfants Malades | Paris | 75015 | France |
| University Hospital Frankfurt M | Frankfurt | 60596 | Germany |
| K J Somaiya Super Speciality Hospital & Research Centre | Mumbai | Maharashtra | 400022 | India |
| Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico | Milan | 20122 | Italy |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Chung Shan Medical University | Taichung | 40201 | Taiwan |
| China Medical University Hospital | Taichung | 40447 | Taiwan |
| Taichung Veterans General Hospital | Taichung | 407 | Taiwan |
| Istanbul University Oncology Institute | Istanbul | 34093 | Turkey (Türkiye) |
| Ege University Medical Faculty Hospital | Izmir | 35100 | Turkey (Türkiye) |
| Nottingham University Hospitals NHS Trust | Nottingham | NG7 2UH | United Kingdom |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 5, 2025 | Dec 19, 2025 | 18 | ||
| Jan 21, 2026 | Feb 5, 2026 | 19 |
| ID | Term |
|---|---|
| D002836 | Hemophilia B |
| D006467 | Hemophilia A |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D040181 | Genetic Diseases, X-Linked |
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| ID | Term |
|---|---|
| D011486 | Protein C |
| ID | Term |
|---|---|
| D004792 | Enzyme Precursors |
| D045762 | Enzymes and Coenzymes |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011498 | Protein Precursors |
| D019774 | Blood Coagulation Factor Inhibitors |
| D001685 | Biological Factors |
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